Neelam Sharma MS, Lavanya Kundurthy BE and Hemant N. Joshi, PhD, MBA# - Tara Innovations LLC, #[email protected]; www.tara-marketing.com
This quarterly review on New Drug Applications (NDAs) contains data on applications approved for the first time during the second quarter of 2022, which includes small molecules and new biologics. A total of 35 applications were approved by FDA during these three months.
The second quarter 2022 approvals were divided into nine different dosage forms. Following are the percentages of those dosage forms – Injection (40.5%), Tablets (18.9%), Capsules (10.8%), Gases and Oral liquids (8.1%), Topicals (5.4%) and 2.7% each of films, oral pellets, and inhalation powders. Following are the submission classifications – gases (3), BLA (3), Type 1 (New molecular entity, 6), Type 2 (New active ingredient, 3), Type 3 (New dosage form, 6), Type 4 (New combination, 1), Type 5 (New formulation or manufacturer, 13), Type 10 (New indication, 1) and unknown (1).
Vijoice (alpelisib) is the first and only treatment for patients with PIK3CA-related overgrowth spectrum (PROS). PROS is characterized by atypical overgrowths and anomalies in blood vessels, the lymphatic system, and other tissues. Only about 14 people in a million suffer from PROS. The most common adverse events are - diarrhea, stomatitis, hyperglycemia, and cellulitis.
Camzyos (Mavacamten) is the first and only approved cardiac myosin inhibitor. It is used to treat adults with symptomatic obstructive hypertrophic cardiomyopathy (HCM). It works by relaxing the muscles in your heart. It may help to increase your ability to exercise and improve symptoms such as shortness of breath and tiredness. Camzyos may cause serious side effects, including heart failure.
Phathom received two approvals – for Voquezna triple pak (amoxicillin, clarithromycin, and vonoprazan fumarate) and Voquezna double pak (amoxicillin and vonoprazan fumarate). Both products are to treat H. Pylori infections in adults. Phathom Pharmaceuticals focuses on developing and commercializing new treatments for gastrointestinal (GI) disorders.
Amvuttra (Vutrisiran) Subcutaneous Injection 25 mg/0.5 mL is given once every three months to treat polyneuropathy caused by an illness called hereditary ATTR amyloidosis in adults. The drug comes with a warning of reduced serum vitamin A levels. Vutrisiran is a chemically modified double-stranded small interfering ribonucleic acid (siRNA) that targets mutant and wild-type transthyretin (TTR) messenger RNA (mRNA) and is covalently linked to a ligand containing three N-acetylgalactosamine (GalNAc) residues to enable delivery of the siRNA to hepatocytes.
Epsolay cream contains benzoyl peroxide and it is indicated for inflammatory lesions of rosacea in adults. Benzoyl peroxide is an oxidizing agent with bactericidal and keratolytic effects, but the precise mechanism in the treatment of rosacea is unknown. The warnings include – hypersensitivity, skin irritation and increased sensitivity to sunlight.
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